We use cookies to customise content for your subscription and for analytics.If you continue to browse Lexology, we will assume that you are happy to receive all our cookies. For further information please read our Cookie Policy.

The Hatch-Waxman Act only authorizes a counterclaim to correct or delete a patent number or expiration date listed in the FDA Orange Book; an ANDA defendant does not have standing to challenge any other listed information, including the use code description

Whether the inventorship of the patents as issued is correct does not determine the materiality of the statements in this case, just as whether concealed prior art would actually invalidate the patent is irrelevant to materiality

Though a district court is not required to state findings or conclusions when ruling on a motion under Fed. R. Civ. P. 12 or 56, the court must provide its reasoning somewhere in the record when its underlying holdings would otherwise be ambiguous or unascertainable

The International Trade Commission ("ITC") issued an exclusion and cease and desist order on importation of certain Global Positioning System ("GPS") devices and products after finding that the devices and products infringed certain patents